Non-Invasive Biomarkers for NASH Clinical Research Studies

Posted: October 8, 2020

Biomarker Assays for
NASH Clinical Trials

Cytokeratin 18 (CK18 and ccK18):
Non-invasive biomarkers for assessing hepatocyte apoptosis and necrosis

Biomarker Utility in NASH Clinical Trials Available Assays Catalog #
Total CK18 (M65®) Biomarker for hepatocyte cell death (apoptosis and necrosis) M65® ELISA P10020
M65® EpiDeath ELISA P10040
caspase-cleaved CK18
Biomarker for hepatocyte apoptosis M30® Apoptosense ELISA P10011


The Problem:

  • In early phase NASH trials, performing liver biopsies to evaluate the effect of a potential drug candidate is not always practical or feasible.
  • These relatively short-duration early trials may not result in significant changes in liver histology.
  • Traditional non-invasive biomarkers for NASH, such as serum ALT and AST levels, are notoriously insensitive and non-specific, and do not always accurately reflect the extent of liver injury.

The Solution: Non-Invasive, mechanistic biomarkers that are reflective and predictive of changes in liver histology

  • Serum CK18 (M65®) and ccK18 (M30®) measure hepatocyte apoptosis and necrosis.
  • Apoptosis and necrosis are underlying mechanisms that are directly involved in the pathogenesis of NAFLD
  • Changes in CK18 and ccK18 levels may therefore be early indicators for changes in disease activity in response to drug treatment.
  • Changes in serum CK18 and ccK18 levels have been shown to correlate with histological changes in the liver.

Additional NASH Biomarker ELISAs from Diapharma

Use M30® Apoptosense® and M65® ELISA as part of your mechanistic biomarker panel to get a fuller picture of effects of your drug candidate.

Visit for our full portfolio of assays, including:

Collagen IV • L-FABP • FGF-19 • FGF-21 • Fibronectin • hsCRP • Mac-2-BP • Noggin • NGAL • Osteopontin • PAI-1 • sCD163

Research use only in the U.S. and Canada. Not for use in diagnostic procedures.


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